Iovance Biotherapeutics, Inc.

Director

• Represent Iovance Medical Affairs as a TIL cell therapy expert in both internal and external venues including the US and Global cross-functional teams, MRB, external consults, clinical sub-teams, and advisory boards / steering committees.
• Work cross-functionally to support Commercial Quality, Market Access, Clinical Development, and the broader Med Affairs team.
• Participate in various Medical Affairs cross-functional working groups.
• Represent Iovance at professional meetings, congresses, and local symposia.
• Provide high quality clinical input and review of disease strategy plans, slides, manuscripts, educational materials, IIT protocols, steering committee and advisory board meeting objectives, Standard Response Letters, and Commercial Brand plans.
• Partner with Scientific Communications to develop timely publication strategies and plan, gap analysis, and key messages.
• Interaction with key stakeholders, as a therapeutic area medical strategy expert.

Scientific Director, Medical Affairs

Manager

• Subject matter expert in diverse molecular biology, protein expression, and biochemistry. An understanding of analytical methods is preferred.
• Manage and/or support knowledge management (including product, process, and analytical)
• Manage and/or support process, analytical, microbial control strategy development and implementation, and risk assessment and mitigation.
• Build and support long term business relationships with key Contract Manufacturing Organizations in support of flexible and efficient supply chains.
• Manage and/or support technical transfer and technical/COGS improvement projects. Ensure effective stakeholder engagement and ensure on-time and in-budget delivery.
• Support regulatory CMC and registrational activities for clinical/commercial products as required, with a focus on ex-US.
• Liaise with Quality/Supply Chain on product disposition and ensure continuous alignment with quality/supply chain systems requirements. Support technical investigations, deviations and CAPAs as required. Support and participate in site audits, as required.
• Manage and/or support hiring and development of staff, as required.
• Ensure CMO site operational readiness for manufacturing campaigns/process transfer/change controls/validations; including facilities, equipment, documentation, training.
• Utilize strong operational excellence / lean principles, business acumen, quality-mindedness, and excellent communication skills to develop streamlined, efficient, and robust systems.

Senior Manager, Protein Sciences Upstream

• Subject matter expert in protein purification, drug product formulation, fill, and lyophilization.
• Manage and/or support knowledge management (including product, process, and analytical)
• Manage and/or support process, analytical, microbial control strategy development and implementation, and risk assessment and mitigation.
• Build and support long term business relationships with key Contract Manufacturing Organizations in support of flexible and efficient supply chains.
• Manage and/or support technical transfer and technical/COGS improvement projects. Ensure effective stakeholder engagement and ensure on-time and in-budget delivery.
• Support regulatory CMC and registrational activities for clinical/commercial products as required, with a focus on ex-US.
• Liaise with Quality/Supply Chain on product disposition and ensure continuous alignment with quality/supply chain systems requirements. Support technical investigations, deviations and CAPAs as required. Support and participate in site audits, as required.
• Manage and/or support hiring and development of staff, as required.
• Ensure CMO site operational readiness for manufacturing campaigns/process transfer/change controls/validations; including facilities, equipment, documentation, training.
• Utilize strong operational excellence / lean principles, business acumen, quality-mindedness, and excellent communication skills to develop streamlined, efficient, and robust systems.

Senior Manager, Protein Sciences, Downstream

Business Operations

• Rotate through three of the five areas: Business Analysis, Platform Administration, Technical Development, Project Lifecycle & Release Management, Testing Strategy and Robotic Automation Testing
• Collaborate with departmental stakeholders to gather, document, and validate functional requirements

Business Systems and Salesforce Intern

• Partner with Policy and Payer Marketing on engagement strategy with external partners and formulary decision-makers primarily in national/regional health plans, CMS, integrated delivery networks (IDNs), ATCs, Large physician groups (LPGs).
• Build and drive the US value proposition story for AMTAGVI and pipeline therapies to include but not limited to impact of complete and partial responses on PROs, productivity and future treatment costs and pharmacoeconomic impact of evolving treatment patterns.
• Incorporate health economics, business analytics and competitive intelligence into the development of innovative strategies to gain, improve and defend public and private market access, specifically, pricing (and contracting) strategic planning within Market Access to create innovative proposals to meet public and private payer needs.
• Lead development and maintenance of formulary submission packages, total cost of care US models and other economic modeling and healthcare resource use analyses.
• Support field-based cross-functional teams to provide pharmacoeconomic expertise in access engagements.
• Compliantly manage operations of Iovance Pricing Committee, GTN implications review and update charter and plan agendas to drive development of Committee recommendations.
• Assess clinical and economic data gaps at key accounts and collaborate with internal stakeholders: Medical, Policy, Reimbursement HEOR, Payer Accounts, Marketing, Legal to provide insight into health economic value needs.
• Support Market Access Account team(s) with Payer and Formulary Decision Makers at key congresses, such as PCMA, AMCP, ASTCT as needed.
• Work cross functionally as a liaison with the brand teams to develop, implement, and communicate strategies and tactics to ensure alignment within the Market Access team on key cross-functional priorities.
• Partnering with Commercial Strategy on Market Readiness, trial design and endpoint considerations, FDAMA and value evidence creation and Go-to-Market approach.
• Assist on pipeline products and indications to generate key evidence and value proposition.
• Provide strategic support and clinical-economic content expertise in innovation and partnership opportunities.
• Operate at the highest level of compliance and professional standards demonstrated by embracing ethical decision-making practices and guidelines in all aspects of our organization.
• Serve as internal point of contact for all health care economic policy.

Director, US Health Economic Value Access – HEVA

• The Medical Scientific Liaison will provide clinical and scientific information in response to inquiries about Iovance Biotherapeutics developmental products and future marketed products to physicians, other health care providers, medical centers and staff, health maintenance organizations, and government health agencies.
• Identify, develop, and maintain relationships with regional and national key opinion leaders and support clinical trial site identification and execution.
• Collaborate with other field-based personnel to ensure that Iovance maintains a strong clinical and scientific presence in the field.

Associate Director, Field Medical Affairs, MSL

Marketing

• Leads the development and execution of payer resources, reimbursement resources, end-to-end payer and channel marketing; provides resources to support the market access field team and pull through strategies.
• Understands total cost of care and all aspects of reimbursement (coding, coverage, and payment) for inpatient and outpatient settings across payer segments.
• Develops the value proposition resources and key messages aligned with Brand strategy.
• Supports the Payer Accounts team in strategic and tactical business planning for payers and hospitals, and partners with payers, key institutions, and health economic associations to ensure attainment of market access goals.
• Creates marketing materials to promote payer programs and responsible for PRC internal review process.
• Supports Market Access in internal meeting planning, deck/slide preparation.
• Manages Market Access dashboards, to include Payer Policy reports, Appeals, Trade Agreements, Patient Support in collaboration with Access Operations.
• Ensures compliance with corporate policies and procedures as well as with US/global healthcare laws and regulations.
• Deliver clear, customer-focused and robust AMCP Dossiers in collaboration with US Health Economics Value Access (HEVA).
• Promote payer requirements and incorporate evidence needs into product development strategies and resources for pipeline assets in conjunction with HEVA.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.